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Trial terminated due to feasibility reasons
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This screening study is intended to determine preliminary eligibility of participants who may be potential candidates for GlaxoSmithKline's Adoptive T-cell therapy studies by screening for appropriate biomarkers. No treatment intervention will occur as part of this screening study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with solid tumors and hematological malignancies | Other | Participants with solid tumors and hematological malignancies will be included. No study treatment will be administered in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Screening Platform | Other | Eligible participants who qualify as per this screening protocol may be referred to evaluate adoptive cell therapy in participants with various malignancies, on a separate treatment trial. No study treatment will be administered in this screening study. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Human Leukocyte Antigen (HLA) A Genotypes Status | Blood samples were collected for HLA compatibility testing. Number of participants with eligible human leukocyte antigen (HLA) A genotypes status are presented. Data has been reported for following categories: One HLA Allele Positive, Two HLA Allele Positive, Negative and Ambiguous. | Up to 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Gainesville | Florida | 32608 | United States | ||
| GSK Investigational Site |
IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, up to another 12 months.
A total of 16 participants were enrolled in the study and provided blood sample for biomarker assessment.
This screening study was intended to determine potential eligibility of participants for GlaxoSmithKline's Adoptive T-cell therapy studies by screening for appropriate biomarkers. The study was terminated early due to feasibility reasons.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Non-small Cell Lung Cancer (NSCLC) | Participants with NSCLC were screened for appropriate biomarkers for an intended adoptive cell therapy on a separate treatment trial. No study treatment was administered in this study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Non-small Cell Lung Cancer (NSCLC) | Participants with NSCLC were screened for appropriate biomarkers for an intended adoptive cell therapy on a separate treatment trial. No study treatment was administered in this study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Human Leukocyte Antigen (HLA) A Genotypes Status | Blood samples were collected for HLA compatibility testing. Number of participants with eligible human leukocyte antigen (HLA) A genotypes status are presented. Data has been reported for following categories: One HLA Allele Positive, Two HLA Allele Positive, Negative and Ambiguous. | Enrolled population included all participants who provided sample for biomarker assessment. | Posted | Count of Participants | Participants | Up to 2 weeks |
|
All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 2 weeks
Enrolled population was used to assess all-cause mortality, non-SAEs and SAEs which included all participants who provided sample for biomarker assessment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants With Non-small Cell Lung Cancer (NSCLC) | Participants with NSCLC were screened for appropriate biomarkers for an intended adoptive cell therapy on a separate treatment trial. No study treatment was administered in this study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 22, 2021 | May 24, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 28, 2022 | May 24, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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|
| Waterloo |
| Iowa |
| 50701 |
| United States |
| GSK Investigational Site | Springfield | Missouri | 65807 | United States |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.